FDA records indicate that there are no current recalls for this drug.
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Flu And Sore Throat Recall
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Questions & Answers
Side Effects & Adverse Reactions
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- to make a child sleepy
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- with any other product containing diphenhydramine, even one used on skin
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- the blood thinning drug warfarin
- sedatives or tranquilizers
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- marked drowsiness may occur
- excitability may occur, especially in children
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse, or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling us present
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- to make a child sleepy
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- with any other product containing diphenhydramine, even one used on skin
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- the blood thinning drug warfarin
- sedatives or tranquilizers
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse, or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling us present
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- for the temporary relief of the following cold/flu symptoms
- minor aches and pains
- headache
- runny nose
- sneezing
- itching od the nose or throat
- sore throat
- nasal and sinus congestion
- itchy, watery eyes
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Flu And Sore Throat Manufacturers
- Cvs Pharmacy
Flu And Sore Throat | Cvs Pharmacy
do not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours children under 12 years of age: do not use - Select Brand Dist.
Flu And Sore Throat | Select Brand Dist.
do not use in infants do not exceed recommended dose (see overdose warning) use dosage cup provided tbsp = tablespoon, mL = milliliter age dose adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours children 4 to 11 years do not use unless directed by a doctor children under 4 years do not useDo not take more than 6 doses (12 tablespoons) in 24 hours.
- Safeway
Flu And Sore Throat | Safeway
do not use more than directed – see Liver warning take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor adults and children 12 years of age and over dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. children 4 to under 12 years of age consult a doctor children under 4 years of age do not use if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat. - Kroger Company
Flu And Sore Throat | Kroger Company
do not use more than directed – see Liver warning take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor adults and children 12 years of age and over dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. children 4 to under 12 years of age consult a doctor children under 4 years of age do not use if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
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